Assisted Dying coming to Canada

What a week this past week has been. While I was away on a business trip to Europe the Supreme Court of Canada (SCC) let it be known that it would release on Friday this week its decision on the so-called Carter case, that is, it would pronounce on the constitutionality of the bits and pieces in our Criminal Code that criminalise assisted dying.

Unless you have lived under a rock during these last few years you will know that I spent a significant amount of my time arguing in favour of the decriminalisation of assisted dying in the country, no least in a report of an expert panel the Royal Society of Canada asked me to chair, on end-of-life decision-making in Canada. In addition I wrote a large number of newspaper columns on the issue and gave oodles of TV interviews and what-not to advance that cause.

So, there I was holed up in hotel rooms in Brussels and Geneva trying to respond to media inquiries. Fearlessly I predicted that the court would come to a unanimous decision and that it would decriminalise assisted dying. I couldn't see, given what we know from jurisdictions that have decriminalised, that the Justices would fall for the slippery-slope clap-trap rolled out by religious opponents of assisted dying, and, of course, their biggest ally, the current Attorney General of this country. I also couldn't see that the Justices would wilfully ignore consistent opinion polls suggesting that overwhelming (I mean: more than 80%) majorities of Canadians are in favour of a change toward making assisted dying available.

It turns out, I was right. The SCC came down with this unanimous decision, defining thus who would be able to receive assistance in dying: a 'competent adult person who (1) clearly consents to the termination of life and (2) has a grievous and irremediable medical condition (including an illness, disease or disability) that causes enduring suffering that is intolerable to the individual in the circumstances of his or her condition.'

This is pretty much what we recommended in our report. What I find particularly important about these criteria is that the Justices rejected a threshold requiring that patients must be in a terminal condition, or near the end of life. The current legislation, on this count, in Quebec, will have to be re-written. At the last minute opponents of Quebec's legislation added this threshold, and, thanks to the SCC decision, it will have to be taken out of Quebec's legislation again as it would unjustly deprive people of access to assisted dying who are not close to the end of their lives.

I think, among the important lessons to be learned from all this, is this one: Opponents of assisted dying should reconsider their campaign strategies. They decided that telling anecdotes from jurisdictions that have decriminalised, making up a lot of stuff about things that allegedly happened in such jurisdictions and telling half-truths about what allegedly happened in jurisdictions that have decriminalized worked in their religious echo chamber of pro-life websites, as well as with allied newspaper columnists like the National Post's Barbara Kay and the Toronto Star's Rosie DiManno, and so it would probably work with Supreme Court Justices, too. Turns out, Supreme Court Justices are a bit smarter than DiManno and Kay, who have shown themselves clueless about the issue at hand throughout their years of campaigning in their newspaper columns against assisted dying. The judges looked at the actual evidence and 'rejected the argument that adoption of a regulatory regime would initiate a descent down a slippery slope into homicide.'

The other vacuous agitprop campaign tool deployed by this camp was their ever-growing concern for 'the vulnerable'. Given that they didn't want assisted dying available to anyone, they were careful never to define 'vulnerable'. Turns out, they and their government ally, the Attorney General, really meant everyone. Vulnerability ceases then to be a useful threshold criterion for anything. The Attorney General eventually said, on the Court record, that 'every person is potentially vulnerable.' The Supreme Court called curtains on this rhetoric, too. It states point blank, 'We do not agree.' - 

Aggressive lying and fudging of the issues apparently takes you only that far when it comes to Canada's Supreme Court Justices.

I wonder whether one analysis in the judgment (paragraphs 64-66) could be interpreted as rejecting the Catholic acts and omissions doctrine. Check that one out yourself. Worth a read.

Restorative justice Dalhousie University style

5 Jan 2015 Update on the post below. Dalhousie University announced today that the dental students in question have been suspended from participation in clinics. Apparently they would still be able to attend classes with the fellow female classmates that were the subject of their rape fantasies. Mind boggling. -----

Quite remarkable events are occurring currently at Dalhousie University's Dental School. They take place against the backdrop of an ongoing international outcry about alleged or real rape cultures on university campuses across North America.

 

What happened at Dalhousie is that a bunch of male dentistry students made on a private Facebook page statements celebrating the rape of female fellow students, they reportedly ranked these women for 'hate sex', fantasized about chloroforming them, then raping them, the list goes on.

 

Invariably there has been talk about boys will be boys, immaturity and whatnot. The truth, however, is that these men are adults. They have just about completed a graduate program in dentistry. Here are a bunch of screenshots from their little FB horror show. Misogyny is apparently not a phenomenon limited to student conduct at Dalhousie's School of Dentistry.

 

If the reported facts are correct, I cannot see how any of these students could possibly be permitted to complete their studies and graduate. I also cannot see how anyone could provide them in good conscience with a license to practice dentistry. These students are clearly unfit to become health care professionals. It is that simple. Vulnerable patients should be wary of any regulatory body that saw fit to provide such people with a license to practice dentistry.

 

Given that these students are at the end of the 4th year, one also has to wonder how effective the Dental School's professional ethics education has been.

 

Well, you'd expect that a professional school would simply eject students that demonstrably committed such offences. Not so at Dalhousie. Its President decided to embark on a restorative justice course of action. He is supported by an unsigned letter purportedly from a Dalhousie Feminist Legal Association. The anonymous authors of the letter clearly love restorative justice. Thing is, Dalhousie, prior to engaging in its restorative justice activity, didn't even bother checking with all of the women named in the Facebook group posts whether they thought that that would be an appropriate course of action. At least one of the women named in the Facebook group's messages is explicitly opposed to the informal restorative justice process. She calls the whole idea 'shocking'. It is clear today that there was no consensus among these women about this approach. That alone calls into question its appropriateness.

 

I am not sure where I stand with regard to restorative justice activities. I find the whole idea to subject the victims of violence or abuse to the need to talk to their abusers, make the latter understand and whatnot pretty silly stuff. I can see that it might work in terms of rehabilitating someone, but really, why should that be a victim's job to begin with? In South Africa the Truth and Reconciliation Commission seems to have been a bit of a failure. Many of those whose loved-ones were murdered by the apartheid regime weren't quite happy that everyone was forgiven by the TRC, provided they showed enough contrition - fake or otherwise. You talk to Black South Africans in the streets of, say, Johannesburg today and you'll hear that very many of them think that they were robbed of justice by the activities of the TRC.

 

For the men involved in the Facebook group this restoration exercise provides a shot at walking away scotch-free provided they show enough contrition and reach some consensus with their victims. The fact of the matter is that there will never be a realistic chance of telling whether they have shown genuine insight or whether they were focused on becoming dentists, no matter what. They have been told that they might still be expelled from University, so they have every incentive to grovel as sincerely as they can, no matter what their actual views on the subject. Here is some indication regarding their capacity to show insight and remorse.

 

Meanwhile, come Monday morning, the women subjected to rape fantasies by their male classmates will be lucky enough to face them again in class and dental clinics while the restoration show gets on the road. Is this mind boggling? Not just a little bit. One wonders what's going on in the minds of senior management at Dalhousie.

 

In any case, the university remains responsible for disciplining students that violate its codes of conduct. Several faculty members of the university have lodged a formal complaint that should have triggered a formal investigation (quite distinct from the informal and ultimately toothless restoration exercise). They wrote this letter on December 21, 2014 to Dalhousie's Acting Vice Provost for Student Affairs. The faculty members have not heard back since then. Keep in mind, on Monday these students will be back in class.

 

These faculty members called it right. They asked for a formal disciplinary investigation and a suspension of the students while the investigation is under way. They realised that permitting these men to continue attending classes will not be a cost neutral activity to many of their female classmates. Apparently even this insight is lost on the Dalhousie administration. 

 

While there is nothing per se wrong with following the informal process of restorative justice, it clearly is insufficient to address the problem at hand. A formal disciplinary investigation is called for, independent of the restorative justice exercise. The men involved and identified in the Facebook postings should be suspended until that formal investigation has run its course.

Academics running OA journals - a new variety of academic self-exploitation?

An interesting phenomenon can currently be observed in the humanities - academics engaging in new forms of self-exploitation. It's linked to the OA hype gripping the academy. How does it work?

Well, in the old days for-profit publishers essentially took over the production and distribution of our peer reviewed content for us. We managed the academic side of the process (peer review etc), they managed the rest. They made (well, still make) a killing on our labour by virtue of being able to force university libraries to pay often exorbitant subscription fees so that we can access research that we produced in the first place.

Came OA, the idea that research paid for mostly by taxpayers should be made available free of charge to anyone anywhere. I call this the having-your-cake-and-eating-it model. Academics typically loves these sorts of models. Thing is, you can't actually have your cake and eat it. OA turned out to be - by and large - a model whereby costs were switched to the producers of the research. Academics suddenly had to pay huge amounts (typically these days about 3000  $ per pop) to be able to play (hence I coined these publishing models 'pay-to-play'). So, while in the not so great old days our libraries were bled dry by greedy publishers, under the new model the only academics capable of publishing their research outputs would be those with research funds able to cover those fees.

That can probably work for folks in the STEM subjects, but this can't work for humanities scholars. Most of us typically produce our research during term breaks, most of us don't sit on large quantities of research funding. In fact, most of us don't have research funding at all.

Here kicks the self-exploitation model in that I started of with. Some well-intentioned humanities scholars have since decided to set up their own OA journals, where neither readers pay, nor those who submit their content for review. Given that barriers to entry are fairly low these days (you need a webserver and publishing software), that is prima facie not a terrible idea. And yet, it does sound like yet another having-your-cake-and-eating-it model, doesn't it? It kind of is. Essentially, those who run those journals have embarked on a never-ending journey of self-exploitation. Nobody pays for anything, you volunteer your time (in return for your name on a journal website masthead), you rely probably to some extent on grad students and postdocs to keep your enterprise afloat, you divert research funding to keep the administrative side of your publishing operation ticking, universities provide the web-server, etc.

The reality here is that academics so volunteer to undertake the tasks publishers (be they OA or subscription based) typically undertake. Will these academics see a benefit from the institutions whose libraries would save large amounts of money if this model took hold (there would be no costs involved in subscribing to journals or in submitting content to them)? The long and short of it is that that is not the case. That funding will disappear elsewhere (a new soccer stadium anyone? new Principal's residence? ) So, really we see a case of academics exploiting themselves, no more, no less. They volunteer their time to undertake administrative (ie journal publishing) tasks that other professionals should undertake, and that these professionals should be paid to undertake, and that these professionals have been undertaken for a very long time.

Now, I'm the last to think that an argument from tradition is a good argument, but it is worth noting that the model whereby those who produce journals are paid for their labour has worked pretty well for us in the academy. You can have a legitimate argument about the cost side of things, about publishers' ever diminishing support services to academic journals, all of that, but fundamentally things work.  We get our content out in reputable academic journals, and the content is available ever more easily and at ever greater speed to other academics. On the other hand, the publishing landscape is littered with the corpses of journals that relied on volunteers to keep all aspects of their operations alive because they insisted on being 'free'. The truth is though, well-paid academics spend their time undertaking administrative tasks involved in producing these journals when they could be doing actual research, teach, or provide other services to their employers, ie the universities where they work.

There was a time when I was worried about what would happen to the published peer reviewed content after the failure of these kinds of publications. Would they also disappear into the rubbish bins of the internet? Thankfully that doesn't have to be the case. We have today numerous repositories where such outlets can store their articles after their demise. So, as long as that occurs, at least the content can survive the demise of the journals themselves.

Still, if I was a budding academic thinking about where to place my first or second peer reviewed journal article, would these kinds of journals be my first choice? Probably not.

National Post commentator makes up stuff about assisted dying

Andrew Coyne, well-known conservative part of Canada's commentariat, makes up stuff about assisted dying today. He deploys in his commentary pretty much every variety of slippery slope arguments that is known to humankind (they're usually all false, folks learn that in Logic101 classes). Bioethics students to the front. Whoever finds the most errors in Coyne's piece wins my last book :).  Inbox me with your findings.

This is in part what he writes:

"Udo Schuklenk, professor of bioethics at Queen’s University and chair of the Royal Society of Canada’s panel on “End of Life Decision Making,” recently published a paper advocating the euthanizing, with parents’ consent, of infants with severe deformities, a practice he likened to “post-natal abortion.” Eike-Henner Kluge, former director of ethics for the Canadian Medical Association, has made similar arguments for including the mentally incompetent among those eligible for euthanization. This is hardly a theoretical concern. In countries where assisted suicide/euthanasia has been legalized, it is increasingly the practice. Belgium, where euthanasia on the Quebec model has been legal since 2002, this year extended it to children, joining the Netherlands, where it has been lawful since the 1990s. In Switzerland it is permitted to euthanize the mentally ill. And the list continues to grow: prisoners serving life sentences are the latest addition. What begins in compassion, it seems, ends in eugenics."

Let me just note here that my contribution didn't once mention 'severe deformities', but hey.  I didn't even mention deformity by some other name as a relevant decision-making criterion. Making up stuff - steady as they write.

Coyne then claims that infanticide is increasingly the practice in countries where assisted suicide and/or euthanasia have been legalized. It turns that the published data cited in my paper show that the opposite is actually the case. Cases whereby the lives of newborns have been terminated whose continuing life-preserving treatment would have been futile have halved in the Netherlands (one of Coyne's straw men) since the mid 1990. Worth noting, virtually all of these life endings were not caused by acts of euthanasia, the act that excites Coyne so much. So, assisted dying does demonstrably not lead to a situation where infanticide is increasingly the practice, the opposite is the case actually.

Slippery slopes typically claim (as Coyne does) that as a result of the slippery slope more (rather than less) cases of something wrong occur. Coyne doesn't even engage the question of whether there might be good reason for why these newborns' lives were terminated by active means or by means of withholding life-preserving care. To him it's all bad. Nothing wrong with living life in a simple world unencumbered by facts. In this case, it's a world of make-belief, because these kinds of cases actually halved in number since the mid 1990.  Then Coyne moves seamlessly from infanticide to the mentally ill. Well, mental illness doesn't necessarily render you incompetent, legally or ethically.

Coyne's apocalyptic journey ends where it must end, in good ol eugenics. Case closed. Has he provided any evidence for this claim at least. Oops, no, that's where this rambling anti-euthanasia commentary abruptly ends.

Let me leave you with a bit more of Coyne's musings. He writes in the same piece, 'Advocates, impatient with such arbitrary distinctions as that between suicide and assisted suicide — of what use is the right to kill oneself, they ask, if you are physically incapable of carrying it out? — are nevertheless at pains to preserve the distinction between terminal illness and mere depression...' . I'm not a professional commentator, so let me just note with some bewilderment that I do indeed think that there's a different between what's commonly understood to be a terminal illness (say, late-stage cancer) and depression. They are simply different kinds of illnesses, one kills ya, the other one doesn't. Apparently, to a commentator on a roll it's all the same, kinda.

I'm always puzzled under what rocks major news organizations find these people. In the good old days they'd have had fact checkers at least that would have fixed (and re-written) Coyne's piece, today, they write and upload at manic speed. Oh well.

Conservative and Liberal Canadian Senators bring assisted dying bill on the way

Conservative Ontario Senator Nancy Ruth and Liberal British Columbia Senator Larry Campbell have introduced today an assisted dying bill in the Canadian Senate. They hope to have it voted on during the spring session of the House. From there it would proceed to the House of Commons for further deliberation and eventual vote.

You might recall that Conservative MP Stephen Fletcher introduced such a bill in the House of Commons, but it was killed there by procedural means by a government determined not to be associated with legislation that's broadly in sync with what more than 80% of Canadians want to see happen in the country.

We will see how this pans out. With a bit of luck it adds further momentum to the currently ongoing Supreme Court of Canada case. Certainly anything helping the momentum toward the decriminalization of assisted dying in the country is to be applauded.

Given that we are going into a federal election in 2015, I can't wait to see how the parties' head honchos and election strategists will try to wriggle their way out of this one. It's a topic that political parties and their parliamentary voting drones try to avoid as much as the plague, despite overwhelming societal support for such a change. - It goes without saying, the honourable exception was Bill 52 in Quebec, there introduced with cross-party support.

The Senate bill reportedly differs from MP Fletcher's bill in three respects:

• It clarifies the roles of the assisting physician, the consulting physician, and who can be official witnesses.
• It requires doctors to report to their provincial ministry that they have assisted with a death and provide a certificate with all relevant details
• It requires a 14-day waiting period after a patient's first request to a physician for help with dying, followed by a second conversation to confirm the patient's wishes

 

Globe and Mail misleads about HIV/AIDS legal basics and vaccine research

Hmm, the Globe and Mail newspaper, Canada's only paper that comes reasonably close to being a national quality outlet, decided to contribute to today's World AIDS Day by offering a list of nine things we should know about HIV.  Good idea, questionable execution.

Under point five the paper informs us in the subheading going with point five (out of nine)

'5. In Canada, it’s is illegal for HIV-positive people to have sex without disclosing their status.'

Except... it isn't actually illegal for HIV-positive people to have sex without disclosing their status. As the journalist responsible for the list notes in the paragraph right under the subheading,
'A more recent Supreme Court ruling stated that a person living with HIV does not have to disclose their status before having vaginal sex if a condom is used and the person has a low viral load.'

That's actually the case. Canadians who happen to be HIV-positive, have an undetectable viral load and use condom during sexual intercourse are not under a legal obligation to disclose their HIV-status to their sex partners.

Important lesson. Make sure to scan more than just the subheadings of the Globe and Mail.

The journalist writing up the nine point list of random 'facts' made up another 'fact' altogether:

'8. The first and only preventative HIV vaccine is being developed in Ontario, but it still has a way to go.'

Reality check:  lots of preventative vaccine candidates are being tested in clinical trials. They pretty much all flamed out to date without doing much. The Globe and Mail journalist responsible for the nine point list links this particular 'fact' to a 2013 article in a business paper alerting readers to the fact that a team at Western University succeeded in testing their vaccine candidate in a phase 1 clinical trial. Phase 1 clinical trials only test for toxicity, no more. So, the long and short of it is that nothing much is being 'developed' on the preventative vaccine front in Ontario. Here's the Globe and Mail take on this: 'Preliminary clinical trial results appear positive but there are still many hurdles to overcome, including manufacturing and regulatory approval.' That's a funny way of looking at a vaccine candidate that has - according to the report the Globe and Mail article uses as reference - barely emanated from phase 1. If you think that manufacturing and regulatory approval are the relevant hurdles to take when it hasn't been established that the agent actually works as a preventative agent, you might want to reconsider your investment strategies as far as pharmaceutical companies are concerned.

This hyping of clinical research in the absence of firm evidence seems to become standard journalistic operating procedure in this country, ever since experimental agents were randomly promoted to Ebola vaccines by eager journalists across the country.

Check out the Globe and Mail piece, some of the other 'facts' seems suspicious, too, but I don't have the time to fact-check this particular list of 'facts' in detail.

In Saskatchewan, where the prevalence rate is three times the national average, a person is infected even more frequently.. A person is infected with HIV in Canada every three hours.

In Saskatchewan, where the prevalence rate is three times the national average, a person is infected even more frequently.

Health Canada Badly Fails Canadians at Risk for HIV Infection

A surprising tweet landed in my inbox some time late yesterday afternoon. Health Canada issued a 'warning' about OraQuick in Home HIV Test. It's currently available for sale on the Canadian site of Amazon. Now, you might think, what qualms could one possibly have about Health Canada issuing a warning about this HIV self-test kit? It might be untested, not doing what it promises to do, etc etc. Makes sense then that the agency 'has initiated compliance and enforcement actions', as it notes darkly on its website, showing its regulatory teeth where it purportedly matters. In any case, you might think, why don't people use a self-test kit that has actually been approved by the agency?

Here the plot thickens. Turns out, 'there are currently no HIV test kits authorized by Health Canada for home use.' In other words, our regulator has chosen not to authorize any HIV self-test kits for use by us. Your guess is as good as mine as to why this hasn't happened. Perhaps our draconian and control obsessed public health agencies want to prevent individual access to self-tests. Perhaps there is an assumption by the medical establishment that we're just too daft to administer the self-test. Perhaps there are mistaken assumptions about our ability to cope should the test results give us reasons to be concerned. Countries such as the United States, and the UK as well as quite a few others have given regulatory approval for these test kits. Apparently competent adults are not treated like children in other parts of the world.

So, what about OraQuick's home HIV test? Let's see, here are customer reviews at US pharmacy chain CVS's website. Yep, it's a 5***** product. People who have used it love it. Well, as we all know, people also love homeopathy, so this tells us little about whether a product is good or works. Let's go then to a regulatory agency that, unlike Health Canada, actually does its job. The United States Food and Drug Administration has approved this home test in 2012.

As I said earlier, I don't know why Health Canada is doing such a lousy job on this front and doesn't evaluate and approve HIV home test kits. They work, they are known to be used widely and they serve to make people more knowledgeable about their HIV status who might - for reasons best known to them - do not wish to inform our Public Health Agency of their HIV status. These people are put off testing by the need to see a doctor and get a script to get tested for HIV. This obviously undermines important public health objectives. Fewer people at risk for HIV infection will get tested. Some HIV positive people will remain ignorant of their status and likely pass on the virus to sex partners. It is public health foolishness not to make access to HIV testing as easy as possible. This, of course, conflicts with the never-ending control freakery public health professionals are notorious for.

I understand why Health Canada needs to act on unregistered products being sold in the country. However, there are products and products. This particular product has been approved for use by a serious, better resourced and arguably better functioning regulatory agency than Health Canada, the FDA. Health Canada has failed for years to test (and approve) this particular product. To now go on a twitter campaign and on an enforcement campaign to prevent the sale of this product in the country suggests seriously wrong priorities at the agency. Meanwhile Canadians tired of this nonsense are at least able to hop across the border, go into any pharmacy they fancy and be treated like actual adults. The product triggering Health Canada's 'compliance and enforcement' activities is on the shelves there. Apparently Health Canada has the resources to engage in compliance and enforcement this-n-that, testing and approving sensible products? Not so much.

How about focusing on actual bogus products or products known to be harmful?

On peer review

The debates among journal editors and other academics about the merits or otherwise of particular forms of peer review continue. A growing number of academics in the STEM subjects seem to think that post-publication peer review provides for higher quality control than the traditional post-submission pre-publication review. Their logic is that mistakes in manuscripts are less likely to be found during a process involving only a handful of reviewers. They furthermore argue that post-publication peer review will submit journal articles to scrutiny by a much larger number of readers. Methodological, statistical and other mistakes would almost certainly be found out in post-publication scrutiny with a higher likelihood simply due to the much larger number of expert reviewing (ie reading, analysing and commenting on) manuscripts post publication. It is difficult to argue with this contention, except to note that post publication peer review sites today suggest that only some of the manuscripts there receive such desirable academic community review. What does this proposal mean then for papers that are ignored altogether by peers. Will they still count as some kind of peer reviewed publications or are they just blog-equivalents? Who counts as a reviewer? Would the authors’ best friends be viable options? University administrators and appointments committees will want to know.

Of course, traditional peer review doesn’t preclude post-publication review. It happens that manuscripts that passed pre-publication review are eventually found to be seriously methodologically flawed. Many of those are withdrawn, but reluctant publishers and editors have also gained notoriety by leaving flawed manuscripts in the public domain without errata. Post-publication review depends to some extent on easy access to the manuscripts in question (Open Access being a bonus here), as well as the existence of sophisticated web-based moderated platforms permitting reader-peers to leave comments. It goes without saying that relentlessly profit-driven publishers of academic journals will be reluctant to invest in the staff necessary to manage this process.

I think, for humanities manuscripts, for the time being, pre-publication anonymous peer review remains the way to go. Anonymous peer review guarantees honest reviews from reviewers. Open review, whereby the reviewers and authors are disclosed to each other, will often prevent honest reviews, simply because reviewers inclined to be critical of a particular submission will be reluctant to burn their bridges by speaking frankly to the quality of a particular submission submitted by a close colleague or friend. Anonymous reviews are not in their own right a guarantee of quality. That’s where journal editors step in. They need to evaluate reviewers’ comments and decide what to do if reviewers’ verdicts vary significantly. You might be surprised to learn that this does not happen all that frequently. Reviewers almost always reach similar verdicts.

The challenge today is, of course, to find knowledgeable reviewers. I have lamented this problem here before. Senior colleagues are often reluctant to undertake this vital work. In fact, a few of them refuse to undertake reviews outright. That does not stop them from complaining bitterly if their manuscripts are, in their view, in the review process for an extraordinary amount of time. Perhaps we ought to institute a policy whereby as editors we would be well within our right to refuse to evaluate submissions from colleagues routinely unwilling to accept review requests.

Another issue arises when it comes to sourcing true peers to review particular content. Having now been an Editor of this journal and its companion journal for the last 15 years, I still struggle on occasion to find a suitable competent reviewer for a particular manuscript. It takes time, especially if the subject matter of a particular manuscript is highly specialised, to find the right peer reviewer. At this journal as well as its companion journal our standard operating procedure is that we as Editors have to find appropriate reviewers. We ask authors only in the rarest of exceptions to suggest possible reviewers to us. It turns out that choosing our own reviewers is a good idea, more so than we thought it is. Journals who ask authors for reviewer suggestions have been hit in fairly significant numbers by fake reviews, written under pseudonym by submitting authors, or by commercial outfits in the business of drafting fake reviews.[i] Post publication peer review publications should take note. You never stop learning when it comes to these matters, and sadly, nothing much surprises me any longer. The public or perish culture in today’s universities has clearly led to unreasonably pressures on academics, leading quite a few of us to stray from the right path.

Courtesy of the rise of open access on-line ‘journals’ we have reason to be weary of claims that the papers published in many such venues have been peer reviewed. As I write this, several incidents were reported where bogus papers have been accepted for publication by such outlets, for a processing fee, of course, delivered to the ‘editor’ via PayPal. Bound to be a classic is undoubtedly this one: The authors conjured up a fake paper with the title ‘Get me off your fucking mailing list’, directed at a SPAM Open Access outlet inviting contributions. Their paper was accepted, ostensibly after peer review.[ii] As any academic with a university affiliation will be able to testify to these days, the same outfits don’t discriminate as editors of more discerning journals would, in terms of competence to review particular academic outputs. A journalist employed at an Ottawa based newspaper reports that his submission of a fake article to a dodgy Open Access outfit ended up with him being now inundated with requests to review manuscripts he is utterly unqualified to review for said ‘publisher’.[iii] It is fair to say that on the odd occasion every editor will call on the wrong reviewer for a particular submission, but that is usually caught by the second or third reviewer, usually the invited reviewer declines. Apparently many pay-for-play Open Access publishing operations are primarily concerned about extracting author processing fees out of the submitting authors. That they can only achieve after they accept submitted content.

An issue remains apparently the Conflict of Interest declaration. There are all sorts of standards deployed by all sorts of publishing outfits, grant giving bodies and so on. Let me just say that I think reviewers would be well advised to err on the side of caution when they declare conflicts of interest. One good yardstick would be to ask yourself whether, if you were at the receiving end of your review, you would want to be advised (as an editor) of particular information that you are considering disclosing. Conflicts of interest could include knowledge of the authors’ identity, financial conflicts, but also that you might be an author harshly criticised or praised in the manuscript that you are reviewing. None of this would disqualify you per se from reviewing, but knowing about these potential conflicts would help editors to assess your comments more competently.

It is pretty obvious to anyone who has been in the business of publishing as an author or editor – or both – that anonymous peer review is far from perfect, and it is conceivable that new publishing platforms will eventually lead to the rise of better peer review processes. I for one am looking forward to those.

---

[i] Ferguson, C. 2014. It’s happened again: Journal cannot rule out possibility that author did his own peer review. Retraction Watch November 10. http://retractionwatch.com/2014/11/10/it-happened-again-journal-cannot-rule-out-possibility-author-did-his-own-peer-review/ [accessed November 25, 2014]

[ii] Bealls, J. 2014. Bogus Journal Accepts Profanity-Laced Anti-Spam Paper Scholarly Open Access November 20. http://scholarlyoa.com/2014/11/20/bogus-journal-accepts-profanity-laced-anti-spam-paper/ [accessed November 25, 2014]

[iii] Spears, Tom. 2014. How my fake science paper earned me a shot at an editor's job.  Ottawa Citizen. November 25. http://ottawacitizen.com/news/local-news/ok-no-problem-fakery-is-fine-at-bottom-feeding-journal [accessed November 25, 2014]

Canadian judge rules that First Nations child's survival interests don't matter more than parental choice

In what has been described as a precedent setting case a Canadian judge has decided today that First Nations parents are well within their right to remove her child from hospital care and place it in an alternative healing outfit (registered in Florida as a massage parlour!). The 'doctor' practicing there has no medical qualifications.

Here's the background of the case: The child suffers from childhood leukemia. Standard chemotherapy has a 95% likelihood of complete remission of the cancer. The family in question has decided instead to transfer the child to an alternative healing facility. The child in question is 11 years old. The local Children's Aid Society decided not to intervene, because the parents were providing 'care' to their child. Apparently to the Children's Aid Society it didn't matter at all what the evidence of success for the parental 'care' was. Turns out that it is non-existent. Another First Nations child also 'treated' in said alternative healing facility has since experienced a serious deterioration in her health because leukemia has returned with a vengeance courtesy of the quack treatment meted out by the Florida based quack healer on behalf of the parents. The family paid close to 20,000 $ for the non-treatment of their child by the Florida based operator of said massage parlour.

Remarkably, the judge in the case seems to be buying into the postmodern relativism that drives the argument of the Children's Aid Society. Here's what the National Post reports from the trial

"But Justice Gethin Edward of the Ontario Court of Justice suggested physicians essentially want to “impose our world view on First Nation culture.” The idea of a cancer treatment being judged on the basis of statistics that quantify patients’ five-year survival rate is “completely foreign” to aboriginal ways, he said.
“Even if we say there is not one child who has been cured of acute lymphoblastic leukemia by traditional methods, is that a reason to invoke child protection?” asked Justice Edward, noting that the girl’s mother believes she is doing what is best for her daughter.
“Are we to second guess her and say ‘You know what, we don’t care?’ … Maybe First Nations culture doesn’t require every child to be treated with chemotherapy and to survive for that culture to have value.”

This sounds almost farcical. The judge apparently doesn't think child survival is what's at stake, but the value of First Nations society. A nice sentiment so long as you aren't a vulnerable child desperately needing proven medical care. He is also essentialising aboriginality in an indefensible way. Here's what the CBC reports about the logic underlying his decision, 'Edward ruled that the young girl needs protection, but that the court had also to consider how aboriginal family rights apply in the case. As part of that consideration Edward described the traditional Haudenosaunee creation story to point out that the practice of traditional medicine existed before contact with Europeans.' The one thing that clearly doesn't feature at all as a relevant criterion is that thing some call 'scientific evidence'. Creation stories apparently trump that at any time.  - Surely, the essential question here is this: Should we, as a society override parental care decisions for their children in cases where there is overwhelming evidence that they're harming their children irreversibly, or, as in our case, where the children would die almost certainly?

The long and short of it is that we have always done this. The children's (objective) best (survival) interests trump parental best intentions, parental ignorance, parental fanaticism, parental scepticism with regard to mainstream medicine etc etc. Hospitals routinely override parental decisions by Jehova's Witnesses that refuse life-preserving blood transfusions for their children. And they are right to do so. There is no parental right to kill their children, not even with the best of intentions. Anyone recall the cases of children who died because their parents thought prayers would do the trick?

What is not known is whether these two cases (same hospital) are a result of a communications break-down between the health care professionals and the parents. But even if this was the case, it remains shocking that the Children's Aid Society could possibly justify its inaction with the view that the parents were just trying something different. Since when has the life of a child become so cheap that we leave it to misguided parents who wish to do as they see fit, evidence be damned?

The apparent 'justification' here is that it is a First Nations child. If this is a case of trying to make-up for past injustice, let me just say that this isn't quite a sensible way to go about this matter.

Seems a classic 'only in Canada' kind of event where society falls over itself trying to accommodate even the greatest nonsense. Child welfare clearly isn't that much of a priority. I'm glad to see that the hospital where both children would have been successfully treated took this case to court. Only once the courts of the land decide that child welfare isn't a relevant consideration and that parental good intentions intentions and the value of 'aboriginal culture' supersede child welfare concerns, can they make future treatment decisions that override patient well-being concerns.  

I do hope that the hospital will appeal this decision.

Placebo controlled trials, catastrophically ill patients and access to experimental drugs

Here's the long version of a piece I wrote on this topic for  The Conversation where it was published today (sans a few bits and pieces that I would have liked included). Interestingly enough, the site saw it fit to alert readers of my piece to an article expressing a different point of view. Fair enough, except, when you read said article you'll note that it doesn't link back to my piece.

In the last six months Colorado, Louisiana, Missouri, Michigan and, most recently, Arizona have passed “right to try” laws that allow terminally ill patients to access treatments that have only passed FDA Phase I clinical trials. All patients need is permission from a drug company and a prescription from a doctor.
 

Right to try laws are designed to ensure that terminally ill patients taking part in clinical trials are true volunteers and have no incentive to cheat the clinical trials system as has happened in the past.
 

Recently, these laws have been critiqued as misguided, and the ethics of allowing patients to use experimental drugs are still up for debate. These laws do not guarantee access to experimental treatments and patients may have to pay for them out of pocket.

Critics of these laws worry that alternative trial designs, or access to such experimental drugs outside the clinical trials system will significantly delay the development of effective therapies.
 

Right to try laws are ethically defensible because they give desperately ill patients a choice. They can decide to participate in placebo controlled clinical trials or to access experimental agents as a possible last-chance treatment. The clinical trial system demands that participants are true volunteers. But, without right to try laws, terminally ill patients have no choice but to access these experimental treatments through placebo controlled trials.

AIDS and the origins of ‘right to try’

Throughout the 1980s, AIDS activists and patients fought to change the clinical trials system. Dying from what was then a terminal illness, many people with AIDS insisted on the right to access experimental drugs that had successfully passed Phase I clinical trials.

Phase I trials are designed to establish the toxicity profile of a particular drug. A small group of volunteers (often not more than a handful) test the drug to find out whether it has serious side-effects. They don’t have to be patients, because the objective is to determine what negative effects, if any, the short-term use of the experimental agents could have.

The only option for AIDS patients in the 1980s was to join a post-Phase I placebo controlled trial or go without access to experimental agents that might give them a shot at survival. These drugs trials are typically double-blind. Double-blind means that neither the doctors nor the patients know who receives the experimental agent and who receives the placebo. This aims to eliminate any bias that might arise from patients or doctors knowing who receives what.
 

Taking part in clinical drug trials meant that AIDS patients faced the chance of being assigned to the placebo control group, and not the group receiving the experimental treatment. These patients understood perfectly well the steep odds against these drugs working. But at least there was a chance. The same cannot be said of placebos.

There is a sound methodological reason to test a new experimental agent against a placebo control when we have no gold standard of care. We need to know whether the new agent does better or worse than the existing standard of care. Even in cases where there is no effective or well-developed standard of care we are usually, but not always, justified in undertaking placebo controlled trials.
 

But, we expect patients participating in clinical trials to be true volunteers. Patients need to choose to participate and give first person voluntary informed consent.

AIDS patients charged that the clinical trials system was essentially coercive. To access experimental treatments, these patients were more or less forced to take part in these clinical trials. If they did not volunteer to participate in a placebo controlled trial, they couldn’t access experimental treatments.
 

Many patients grew frustrated with this system and, often in collusion with their doctors and pharmacists, lied and cheated to access particular clinical trials. They analyzed who got placebos and who got the experimental drugs, and shared the drugs. Patients dropped out of clinical trials they believed offered trial designs not conducive to their own survival. Controlled trials become nearly impossible under such circumstances.
 

Undoubtedly this made it harder to get a sense of what drugs worked and what didn’t and may have delayed the development of life-preserving anti-HIV medication.

Drug companies control access to experimental treatments. Taiyo FUJII/Flickr, CC BY

Right to try, but not right to access

Since the 1980s special access protocols have been implemented in the United States, Canada and other countries. These protocols meant to ensure that catastrophically ill patients can access experimental agents outside the clinical trials’ system.

At least in theory. In practice, things are different. Right to try laws do not guarantee the right to access experimental treatments. Even with laws in place, access is still controlled by drug manufacturers.
 

In Canada the government permits people with terminal illnesses to access drugs that are in the clinical trials system, and they can do so without having to participate in the trials. In return they promise to have their doctors monitor the impact of the drug carefully and report it back to the manufacturer or whoever runs the clinical trial.

Access to these treatments depends on the goodwill of pharmaceutical companies keen on recruiting patients into their clinical trials. Drug manufacturers effectively coerce terminally ill patients into their trials by refusing access to the experimental agents. Experimental drugs are sometimes released outside of clinical trials on so-called compassionate grounds, but that doesn’t always happen. Here is just one example of a since deceased cancer patient. Adrienne Cotton died earlier this year. She tried to access a particular experimental drug that was already in a phase 3 clinical trial (we had reasonable evidence that it worked against the cancer that was killing her from phase 2 clinical trials). The medication she was successfully denied access to by the drug's manufacturer has since received market approval as a cancer drug in Japan.
 

And who pays for these experimental treatments? For good reasons insurance plans in the US (or, in Canada, government programs assisting uninsured patients) will not pay for drugs that are untested and are not known to work. As a result of this patients in both Canada and the US must pay out of pocket for these experimental agents.
 

Pharmaceutical companies are free to charge whatever they wish for these agents, and so, arguably, are in a situation to exploit financially desperate dying patients. This also gives them an opportunity to deny patients access in order to coerce them into trial participation. Regulators need to look at this problem as a matter of urgency.

 

Ebola patients subjected to placebo controlled trials

FDA officials and influential former NIH staffers are currently falling over one another propagating placebo controlled trials to test experimental agents on Ebola virus infected patients in West Africa. It goes without saying that impoverished catastrophically ill patients there – in the real world – have no alternative other than to accept the deal on the table. There are methodologically sound alternative trial designs available that do not rely on placebos, yet – much like during the 1980s – the FDA remains intransigent to the human suffering caused by its edicts. Remarkably, trial designs that are not acceptable unless alternative access to the experimental agent is offered in a bunch of of US states are foisted so on desperate African trial participants if the FDA has its way.